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RTF Template

National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A043/04/H/002/2020
2. Name of Authorisation Holder	:	Octapharma - Produtos Farmacêuticos, Lda.
3. Address(es) of Site(s)	:	Estrada da Paiã, Quinta do Lamas, Lote 5 Cave, Zona Industrial da Paiã, Odivelas, 1675-076 Pontinha, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Lagares de EL-Rei, n.º 21 C - R/c Dto., Lisboa, 1700-268 Lisboa, Portugal
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-06-25
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Octapharma - Produtos Farmacêuticos, Lda.

, Estrada da Paiã, Quinta do Lamas, Lote 5 Cave, Zona Industrial da Paiã, Odivelas, 1675-076 Pontinha, Portugal

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

WDA scope activity - Wholesale Distributor.

Updating of the Annex 1 regarding the inclusion of the Immunological medicinal products and Radiopharmaceuticals products.

The Authorisation number A043/04/H/002/2020 replaces the previous one with the Authorisation number A043/04/H/001/2004, of 2004-07-22.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	A043/04/H/002/2020
	Page 1

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